79 Clinical Trials for Various Conditions
A fundamental problem in neuroscience is how the brain computes with noisy neurons. An advantage of population codes is that downstream neurons can pool across multiple neurons to reduce the impact of noise. However, this benefit depends on the noise associated with each neuron being independent. Noise correlations refer to the covariance of noise between pairs of neurons, and such correlations can limit the advantages gained from pooling across large neural populations. Indeed, a large body of theoretical work argues that positive noise correlations between similarly tuned neurons reduce the representational capacity of neural populations and are thus detrimental to neural computation. Despite this apparent disadvantage, such noise correlations are observed across many different brain regions, persist even in well-trained subjects, and are dynamically altered in complex tasks. The investigators have advanced the hypothesis that noise correlations may be a neural mechanism for reducing the dimensionality of learning problems. The viability of this hypothesis has been demonstrated in neural network simulations where noise correlations, when embedded in populations with fixed signal-to-noise ratio, enhance the speed and robustness of learning. Here the investigators aim to empirically test this hypothesis, using a combination of computational modeling, fMRI and pupillometry. Establishing a link between noise correlations and learning would open the door to an investigation into how brains navigate a tradeoff between representational capacity and the speed of learning.
Research has documented positive effects of doctor-patient race concordance, suggesting that increasing diversity among healthcare professionals may play an important role in addressing well-documented racial health disparities in the US. It also remains critical to improve the quality of interactions in race discordant doctor-patient relationships. However, as health systems consider policies to increase the number of minority healthcare professionals, especially among doctors, questions about the equilibrium effects of such initiatives naturally emerge. In this project, the investigators examine whether and how patients vary their perceptions of healthcare professionals by race.
Effective patient education improves health literacy and engagement thus improving long-term health outcomes. Health literacy is imperative to make informed health decisions and relies on the ability to obtain, process and understand health information; and is the cornerstone of safe health management. It is necessary to evaluate educational initiatives to determine their effectiveness in knowledge translation. A more effective way to provide patient education is to utilize media technology. Current education styles do not teach patients in the best way as they are not consistent with how people of all ages currently learn (through technology). In addition, patient teaching most commonly occurs during highly stressful times like hospital visits with new diagnoses. Current patient educational methods are costly given the amount of health provider time required. Electronic KITE teaching modules are infographic visual representations that present information quickly and clearly, integrating words and graphics to tell a story to reveal information. Infographic presentations are tools which facilitate self-directed learning with understandable, accessible information presented in an engaging way with an aim to enhance learning for children and their families. Patients are able to learn at a pace consistent with their learning style to facilitate knowledge development and health literacy.
This is a 3-year prospective randomized comparative study of the efficacy of patient navigation on health education, health related quality of life, healthcare utilization, and medical outcomes in formerly incarcerated individuals. Individuals will be randomized to the patient-navigator intervention or to a care-as-usual control condition. A total of 300 recently incarcerated individuals will be enrolled with 150 subjects each in the intervention and usual care group. The investigators hypothesize that the intervention will improve health education, health related quality of life, adherence to clinical appointments, glycemic/blood pressure control, and virologic suppression in HIV-infected. The results of this study will demonstrate interventions to eliminate health disparities in a highly marginalized group going through the transitional phase of re-entry into the community.
The broad, long-term objectives are to generate and test hypotheses leading to theories that guide improved care of patients with gestational diabetes. The purpose of this chart review study is to evaluate the Vanderbilt Gestational Diabetes Self-Management Education Program and Quality Improvement Plan in optimizing metabolic control and improving health outcomes during pregnancy with gestational diabetes.
The Accreditation Council for Graduate Medical Education (ACGME) acknowledged the changing needs of physicians in training when it endorsed practice-based learning and improvement (PBLI) -- a competency that is typically omitted from medical curriculum. The goal is to have residents competent to investigate and evaluate their own patient care practices, integrate scientific evidence and be able to improve their practices. Available assessment tools do not adequately address all of the components of PBLI and few assessment tools attempt to capture the residents' ability to develop and implement clinically-based Continuous Quality Improvement (CQI) projects that involve the practice setting. Curriculums without such foci miss the importance of system perspectives and opportunities for interprofessional team development. Our aim is to evaluate preliminary data on the curriculum we developed to address the gaps, to develop an assessment tool, and to provide methods for assessing the sustainability of system projects. The key component of the curriculum is the integration of system quality improvement projects. PBLI curriculum was offered on alternate rotations. Preliminary data is available from 6 PBLI QI Systems Curriculum blocks (n=50) and 5 comparison blocks (n=42). Data includes closed- and open-ended questions designed to assess resident PBLI application skills, the notes and presentation slides for the residents' presentation.
The overall goal of this project is to evaluate the effect of enhanced psychological well-being on sleep quality. This study will demonstrate whether combining an intervention designed to promote psychological well-being with sleep hygiene education improves sleep quality in a non-clinical population of distressed adults reporting poor sleep in the absence of a diagnosed sleep disorder. The investigators expect an intervention combining elements of psychological well-being and sleep hygiene education to result in significant improvements in sleep quality measures from baseline to post-intervention, and greater improvements in sleep quality measures at post-intervention as compared with sleep hygiene education alone.
The purpose of this study is to develop and evaluate the effectiveness of taste vs. health messaging using nutrition education videos. The nutrition education videos teach Americans the benefits of using herbs and spices to increase diet quality. The investigators aim to test the effectiveness of 10 short videos (5 taste-based messaging and 5 health-based messaging) that translate previous findings of how spices can improve diet quality. These objectives will be pursued via the following hypothesis: Hypothesis 1: Are taste messaging videos more effective in improving consumer interest, knowledge, and confidence in using herbs and spices compared to health messaging focused videos? Hypothesis 2: Will consumers rate the taste messaging videos higher for liking, engagement, and acceptability of herbs and spices compared to health messaging focused videos?
The purpose of this research is to compare the effectiveness of providing dietary education to complement Intraneural Facilitation® Therapy (INF® Therapy) (a physical therapy technique being evaluated that may help improve circulation) versus INF® Therapy only in adults with a type of neuropathy called distal symmetric polyneuropathy (DSPN).
This trial studies how well exercise and nutrition education work in improving physical function and quality of life in older breast cancer survivors. Exercise and nutrition education may help to improve the level of fitness, cardiovascular health, and quality of life in breast cancer survivors.
Operative vaginal delivery (with forceps or vacuums) is frequently performed secondary to maternal exhaustion, which leads to an inability to push effectively; 40% of operative vaginal deliveries at Prentice are for maternal exhaustion. The risk of severe birth trauma is increased three to four fold with operative delivery. This randomized, controlled trial will compare rates of operative vaginal delivery and severe birth trauma in two groups of women: (1) an intervention group who will participate in the antepartum Total Control® fitness and education program modified for pregnancy; and (2) a control group. Women will be recruited and followed from the second trimester until 6 weeks postpartum; all will complete validated questionnaires regarding their (1) level of worry and knowledge about their birthing experience (2) pelvic floor symptoms and quality of life (3) sexual function (4) satisfaction with their birthing experience and (5) level of depressive symptoms at various time points during and after their pregnancy. Obstetrical data will also be collected.
The objective of this study is to determine whether group educational visits improve the quality of life of patients referred to the Dermatology Clinic. Secondary outcomes will be to determine whether group educational visits influences other key elements of patient care such as topical steroid usage, disease exacerbations, emergency visits, and phone calls to the office. Lastly, the investigators hope to evaluate which aspects of the educational visit were found to be the most helpful to families caring for children with atopic dermatitis (AD). Patients will be new atopic dermatitis referrals to OHSU dermatology and pediatric dermatology clinics. All consecutive patients with such appointments during a three month time period will be screened for participation in the study. Parents will be recruited via telephone. In the intervention group, parents will be invited to participate in a group education visit prior to their first appointment with a dermatologist. All parents in the study will fill out questionnaires. The children involved in the study will be assigned an eczema severity score during their routine visits, but this will be incorporated into the regular clinic assessment. The Childhood Atopic Dermatitis Impact Scale (CADIS) assesses the quality of life in households with children who have atopic dermatitis. The Eczema Area and Severity Index (EASI) measures the extent and severity of the patient's atopic dermatitis. The change in CADIS scores will be analyzed to determine if there is a more significant improvement in quality of life for the group in which parents receive the group eczema education visit.
Although implementation intentions (I2)-based tools enhance colorectal cancer (CRC) screening uptake, prior studies have not tested their implementation into routine primary care delivery. In this study, investigators will conduct a cluster-randomized trial in 20 US primary care clinics. Specific aims for the project will be: 1) to test whether a Normalization Process Theory-informed Participatory Learning in Action (NPT-PLA intervention) implementation of a proven implementation Intentions-based colorectal cancer screening tool ("I2") improves screening uptake (i.e. screening order and completion) within 6 months of patient enrollment versus usual quality improvement (control) implementation; and 2) to evaluate the facilitators and barriers of each implementation arm using the 2022 expanded Normalization Process Theory (NPT) framework. Multi-disciplinary clinic 'implementation teams' that include clinic staff and patients whose preferred language is Spanish will meet monthly during the first 6 months of clinic participation and aim to integrate into routine primary care the "I2" CRC screening tool, using the NPT-PLA intervention or control approach. The I2 tool addresses the "when," "where" and "how" details of stool sample or colonoscopy screening. The I2 tool will be delivered via an on-line survey or (if patients prefer) by paper form customized for use in English or Spanish. At least 100 patients in each clinic will be enrolled in the first 6 months of clinic participation (2000 in total). All patients eligible for CRC screening will be offered the I2 tool. Their choices will be communicated automatically to clinics for order entry. Primary (Aim 1) outcomes will be CRC screening orders placed (by clinic staff); completion of the I2 tool and CRC screening completion (by patients) over 6 months of patient follow-up. For Aim 2, surveys based on the NPT domains (the "NOMAD") will be used to assess staff comprehension of their role in implementing the I2-based CRC screening tool, its salience, their buy-in, feasibility of altering workflows, and the potential impact of using the tool in their setting. Investigators will conduct summative qualitative focus group discussions in all participating clinics after 6 months of clinic participation. The study will provide important information on barriers and facilitators of embedding NPT-PLA interventions in "real-world" primary care clinical settings.
The purpose of this study is to evaluate the feasibility of using a realistic and anatomically accurate 3D printed simulation model for urologic bowel diversion patient education. Using a randomized two group design, we aim to determine whether the use of this model enhances patient knowledge, self-care skills, and confidence in ostomy care. We will also evaluate changes in quality of life (QOL) and patient satisfaction comparing patients exposed to the 3D model to those receiving standard of care. The secondary aim of the study is to examine the differences between groups on patient outcomes including hospital duration, mortality, emergency/urgent health care visits, readmissions, and infections. Participants will be educated using 3D model simulation as part of their preoperative education (experimental group) or have standard education without using the simulation model (comparator group). Both groups will complete quality of life (QOL), ostomy adjustment, and satisfaction with education surveys during their preoperative education visit and again during their routine follow-up visits (a) within 3 weeks after surgery, (b) between 5- 8 weeks after surgery, and (c) at approximately 3 months after surgery.
Youth with epilepsy (YWE) are significantly more likely than their peers without epilepsy to experience isolation, interpersonal victimization, and low relationship satisfaction. This is a serious health concern. Poor social support, real or perceived, is consistently correlated to worsened outcomes in every domain of health-related quality of life. As YWE are two to five times more likely than their peers without epilepsy to develop a mental health condition, poor social support is likely a bidirectional risk factor. Currently, there are no best practices or recommendations for clinicians or other youth-serving professionals to reference when it comes to improving the perceived social support of YWE specifically. The research team has drawn from multiple fields of scientific knowledge to develop a novel intervention that aims to provide YWE with knowledge, skills, connections, and positive emotional support that can help them to bolster their support system at every level of the social ecological model (SEM). The proposed study is a pilot of this intervention to test its acceptability and appropriateness according to YWE participants ages 12 to 26. The intervention's impact on participants social-emotional learning skills and the feasibility of expanding the study protocol for use in a large, multisite randomized control trial will also be explored. The goal of this research study is to help evaluate a new program for young people diagnosed with epilepsy that will build up young people's social opportunities, interpersonal skills, and sources of emotional support. The investigators want to research the impact of this program. From this study, the investigators hope to learn what the program does well, and in what ways it could be improved from the perspective of YWE.
Building on limitations of prior research, the investigators developed the Mindful and Self-Compassionate Care Program (MASC) to help caregivers of persons with Alzheimer Disease and Related Dementias (ADRD) manage stress associated with the general caregiver experience including stress stemming from managing challenging patient behaviors. MASC teaches: (1) mindfulness skills; (2) compassion and self-compassion skills; and (3) behavioral management skills. MASC also provides psychoeducation and group-based training and skill practice to facilitate skill uptake and integration within the caregiver experience and tasks. The main aim is to: Demonstrate feasibility, acceptability, credibility, fidelity, preliminary efficacy and evidence for proposed mechanism of MASC through a pilot randomized controlled trial. Relevant stakeholders (caregivers of persons with ADRD) will participate in the intervention.
This cluster-randomized trial will assess the effectiveness of a precision feedback service on anesthesia provider performance. The precision feedback service enhances a standard audit and feedback (A\&F) email with a brief message and visual display about high-value performance information. The control arm will receive a standard "one size fits most" A\&F email that is currently sent to anesthesia providers each month. Hypothesis: Providers receiving precision feedback will increase a) care quality for improvable measures and b) email engagement (click-through and dashboard login rates) when compared with providers receiving standard A\&F emails. The study investigators will assess unintended consequences in a mixed-methods process evaluation.
The goal of this clinical trial is to test a prototype of a new educational game about environmental health literacy with middle school age youth. The main questions it aims to answer are: * Does playing the game increase knowledge about environmental health? * Does playing the game improve environmental health literacy? * Does playing the game increase interest and confidence in science? Participants will be asked to: * Take a survey at the beginning of the study * Play the game for a minimum of 50 minutes * Take a survey at the end of the study
The purpose of this study is to determine whether participation in the Mobility Opportunities Via Education (MOVE) program is associated with reduced use of healthcare for individuals with developmental disabilities.
The goal of this randomized control study is to determine if the use of standardized coaching language by faculty trainers for teaching colonoscopy is associated with improved colonoscopy performance. The main questions it aims to answer are: * If the use of standardized coaching language is effective in improving colonoscopy training? * If the use of standardized coaching language influences the clarity of instructions by the faculty trainers during colonoscopy teaching Participants will take part in simulated colonoscopy teaching encounter using a virtual reality simulator for 1 hour in 2 different sessions 2 weeks apart. Researchers will compare 2 groups of faculty trainers to to see if the standardized coaching language effects the colonoscopy training quality.
Higher education students 18 years or older will participate in 8- virtual mindfulness meditation sessions over 3 to 4 weeks (minimum of 3 sessions per week). Each session will be 30 minutes long, 15 minutes for guided mindfulness meditation run by researchers, followed by a short discussion period to understand mindfulness meditation better. Before starting the mindfulness meditation session, baseline data will be collected.
Food insecurity and low diet quality are persistent problems linked with chronic disease and poor health among limited-resource children and adults using Supplemental Nutrition Assistance Program (SNAP). We have shown nutrition education via adult-focused, direct SNAP-Education (SNAP-Ed) improved household food security by 25% but not adult dietary quality among SNAP-eligible households using a randomized, controlled, longitudinal SNAP-Ed intervention in Indiana. Households experiencing food insecurity often reserve food considered "healthful" for children, so child dietary quality improvement may precede that observed among adults when household food security improves. This study will determine the effect of adult-focused direct SNAP-Ed on child dietary quality and household food security using a longitudinal randomized, controlled SNAP-Ed intervention. Assessment will include repeated 24-hour dietary recalls to determine usual intake, the U.S. Household Food Security Survey Module, and behavior data from before and after the 10-week "intervention period," and 1 year later, after which the control group will receive the intervention. Low-income participants (n=275) from Indiana will be recruited following SNAP-Ed protocol. Results of the study will inform the creation of supplementary on-demand SNAP-Ed educational material focused on improving healthful dietary intake for children and adults in situations of food insecurity in households with children. Education on modeling healthy attitudes and behaviors, planning and preparing family meals, and dietary shortfalls as informed by the results and previous evidence will be included and evaluated. The study aligns with the goals of USDA to increase food security and this RFP to improve healthful behaviors, food quality and nutrition.
The purpose of this research study is to compare the effect of two different types of education and support programs for partner caregivers of people with spinal cord injury (SCI).
Deviant peer affiliation is one of the most important predictors of alcohol use in adolescence. These affiliations arise when socially marginalized youth self-aggregate and reinforce alcohol use and other deviant activity (i.e., "deviant peer clustering"). Existing efficacious school-based prevention programs generally have small effects and can be difficult to disseminate with fidelity and challenging to sustain due to complex designs and significant time-and-money expenditures required for materials and training. Existing school-based prevention programs have not provided compelling value to schools, which has limited their dissemination. The investigators found significantly lower rates of deviant peer affiliation and alcohol/tobacco use and moderate-to-strong suppressive effects on bullying, victimization, stress, and emotional problems, and strong positive effects on student engagement, achievement, and social-emotional skills in peer-learning intervention schools compared to control schools. However, teachers in intervention schools faced challenges implementing peer learning, including: (1) design fidelity: ensuring that peer learning provided the most positive student experience by including all the essential design elements; and, (2) instructional support: managing the flow and timing of the activities to complete the lesson on time while dealing with unexpected disruptions. Investigators developed an initial version of a mobile software application (PeerLearning.net) that provided easy-to-use organizational templates with workflow support that teachers used to automate the design and delivery of peer learning lessons. In this cluster randomized trial of the app, the investigators will use a sample of middle and high schools and conduct pre/post student assessments of peer relations, alcohol/drug use, antisocial/prosocial behavior, and social-emotional skills. They will also collect information on stress, bullying/victimization and related outcomes, including sleep quality and mental health. Investigators will also collect data on the frequency of lesson delivery with the app by teacher and school to assess dosage, which will be incorporated into our analyses. The investigators hypothesize that use of PeerLearning.net will have significant suppressive effects on alcohol use and related outcomes (i.e., tobacco/marijuana use, antisocial behavior, bullying, emotional problems) and promote increased levels of social-emotional skills and prosocial behavior. The investigators hypothesize that these results will be moderated by dosage (i.e., use of the app), such that greater usage yields larger effects.
This randomized, controlled study will compare Mindfulness Awareness Practices for Insomnia (MAP-I) to sleep health education (SHE) in subjects receiving autologous hematopoietic cell transplant for multiple myeloma.
Evidence-based VA care is best for meeting Veterans' mental health needs, such as depression, PTSD and opioid use disorder, to prevent suicide or overdose. But some key evidence-based practices only reach 3-28% of patients. Participatory system dynamics (PSD) helps improve quality with existing resources, critical in mental health and all VA health care. PSD uses learning simulations to improve staff decisions, showing how goals for quality can best be achieved given local resources and constraints. This study aims to significantly increase the proportion of patients who start and complete evidence-based care, and determine the costs of using PSD for improvement. Empowering frontline staff with PSD simulation encourages safe 'virtual' prototyping of complex changes to scheduling, referrals and staffing, before translating changes to the 'real world.' This study determines if PSD increases Veteran access to the highest quality care, and if PSD better maximizes VA resources when compared against usual trial-and-error approaches to improving quality.
The investigators have designed a psychoeducational group curriculum specifically for new in vitro fertilization (IVF) patients (both male and female) to improve their treatment knowledge, to allow them to engage more in their care, to offer a support network, to improve satisfaction, and to provide them with tools to help reduce their stress and anxiety while undergoing the IVF process. The investigators plan to have four to eight infertility patients and their partners participate in a group at a time, for which they will attend three 1-1.5 hour interactive sessions that are scheduled throughout their first IVF cycle. These sessions will provide additional time for discussion about treatment with providers, learning opportunities on topics of interest to fertility patients, and stress reduction techniques. They will do several surveys before and after the intervention for comparison, including assessment of quality of life, depression, anxiety, resilience, and a knowledge assessment. The investigators will also track the patients to see if they pursue additional treatment in the instance of a negative pregnancy test compared to patients undergoing the standard treatment. The investigators plan to recruit a control group that receives the standard of care treatment here at the University of Iowa.
C-LEARN is designed to determine how to build service program and individual client capacity to improve mental health-related quality of life among individuals at risk for depression, with exposure to social risk factors or concerns about environmental hazards in areas of Southern Louisiana at risk for events such as hurricanes and storms. The study uses a Community Partnered Participatory Research (CPPR) framework to incorporate community priorities into study design and implementation. The first phase of C-LEARN is assessment of community priorities, assets, and opportunities for building resilience through key informant interviews and community agency outreach. Findings from this phase will inform the implementation of a two-level (program-level and individual client level) randomized study in up to six South Louisiana communities. Within communities, health and social-community service programs will be randomized to Community Engagement and Planning (CEP) for multi-sector coalition support or Technical Assistance (TA) for individual program support to implement evidence-based and community-prioritized intervention toolkits, including an expanded version of depression collaborative care and resources (referrals, manuals) to address social risk factors such as financial or housing instability and for a community resilience approach to disaster preparedness and response. Within each arm, the study will randomize individual adult clients to one of two mobile applications that provide informational resources on services for depression, social risk factors, and disaster response or also provide psychoeducation on Cognitive Behavioral Therapy to enhance coping with stress and mood. Planned data collection includes baseline, 6-month and brief monthly surveys for clients, and baseline and 12-month surveys for administrators and staff. Due to COVID-19 pandemic interruption of the study, the recruitment into the randomized controlled trials was halted. A third study part was added to assess the impact of the pandemic on participating study agencies and the community.
Health disparities have been documented in same-sex partnered women, including higher rates of cardiovascular disease, Type 2 diabetes, cancers, and mental health disorders. Higher rates of smoking, substance use, and obesity are behavioral risk factors that contribute to these chronic health problems. Living in rural areas with fewer social supports and less access to culturally sensitive healthcare services may also contribute to health disparities in sexual minorities. Their stigmatized identity is linked to minority stress, a well-documented social determinant of health behaviors and outcomes. Coping responses are an important couple-level mechanism that link stigma-related (minority) stress and health in same-sex couples. Relationship education (RE) programming is a potentially effective approach to increasing positive dyadic-level coping skills that support health. In a sample of 40 female same-sex couples, investigators will test the hypothesis that couples who complete newly revised, web-based RE modules that target health-related coping responses to stigma-related stress will report immediate (post-intervention) and persistent (3-month follow up) positive effects on their relationship quality (e.g., positive communication and problem-solving, relationship satisfaction, perceived partner support), stigma-related coping behaviors, and health (e.g., reduced substance use, depression/anxiety, physical health symptoms). This intervention represents one of the first efforts to test the effects of a culturally appropriate web-based relationship education tool that specifically targets health-related coping behaviors in rural female same-sex couples, a stigmatized, high-risk, under-researched and under-resourced population.
The aim of this project is to determine whether the entire intervention (Mindfulness meditation, AF education, and weekly phone visits) that is nurse delivered to individuals with paroxysmal atrial fibrillation is more effective than a combination, single or no intervention in the reduction of overall AF symptoms, anxiety, and negative illness perception; or the improvement of quality of life (QOL) and functional status.